Today, in almost all applications of surgical invasive treatments requiring a major incision in the skin of a patient which needs to be maintained over a longer period of time, for example, for 30 minutes or for several hours, such treatments are undertaken in an operating room. Such an operating room provides a controlled atmosphere and environment as a whole and allows the patient to be positioned in a sterile space inside the operating room. Generally, this opens the possibility to conduct such a surgical invasive treatment without the risk of infection of the patient following migration of bacteria in the course of the operation. However, this must be considered a theoretical finding in view of the practical circumstances when conducting such a surgical procedure.
In practice, one major aspect for the success of such a surgical invasive operation with regard to being infectionless is the preparation of the patient and the preparation of the persons conducting the operation, such as the surgeon and assisting personnel. Major efforts requiring significant time are made to establish sterile surfaces of the patient, the surgeon, and the assisting personnel and any devices, such as instruments, handles of medical devices inside the operating room, and the like are employed to prevent any source of infection. However, in view of large medical devices, such as x-ray apparatuses, additional imaging devices, and further pneumatically or electrically driven apparatuses, such as the surgical illumination device and the like, a completely sterile preparatory work on all these devices and surfaces is a rather difficult task and thus in single cases no such complete disinfection and sterile environment is reached.
The costs for building and maintaining such an operating room and all devices inside said operation room and the costs for preparing and maintaining such operating room and any such devices in a sterile condition are high. Further, the preparatory work for a surgical treatment takes considerable time, thus not allowing a frequent processing of multiple surgical treatments in one operating room. This provides a significant drawback in particular with regard to surgical invasive treatments wherein such treatments do not take much time and it thus would be desirable to conduct multiple, short time treatments in one operating room, one after the other without significant preparatory work for disinfecting the room and the surfaces.
It is generally desirable to facilitate such invasive surgery treatment with regard to the preparatory work and to increase the safety against infections of the surgery's side in the course of such surgical treatments. Further, it is desirable to reduce the time and effort spent for such a surgical treatment and, in particular, the time spent for preparatory work for such surgical treatment to allow such invasive surgical treatments to be conducted in an environment at lower costs and in shorter time periods.
WO 1986/006272 A1 discloses an isolator for use in surgery. The isolator includes an inflatable bag of flexible material and a device for maintaining a positive pressure in the bag. The inflatable bag can be fixed to a patient and a surgeon can insert his hands into the inflatable bag to conduct a surgical invasive treatment inside said bag. Whereas such a bag having a positive pressure is considered to be safe against invasion of bacteria due to the pressure drop against the environment, the positive pressure inside said flexible bag is considered to bear on the risk of inducing embolism to the patient in the course of the surgical treatment by effecting local clotting or coagulation of the blood and pressing such clotted blood or the pressurized air directly into the body and the circular system of the patient. U.S. Pat. No. 7,037,254 B2 discloses a further device having an inflatable plastic dome to establish a controlled surgery environment by such inside pressurized atmosphere.
The use of such inflatable designs made of flexible sheet material has not shown to provide significant improvement with regard to preparatory work and conducting of surgical invasive treatment. As a first reason for this, the known devices require significant preparatory work on the patient to establish the sterile environment inside the inflatable bag. Further, the preparatory work is further complicated with regard to the planning of the treatment due to the fact that the surgeon is hindered from introducing additional instruments into the inflatable bag once the surgical treatment has started and is further hindered from removing tissue material or fluids out of the inflatable bag during the course of the surgical treatment. Thus, the approach of using such inflatable bags did not find acceptance in practice.
A further aspect considered as a significant drawback of such devices for establishing a local limited controlled atmosphere above a patient's skin for such a surgical treatment is the preparatory work for disinfecting the patient's skin. Such disinfection procedure often hinders a secure and rigid attachment of the inflatable bag to the patient's skin and thus bears on the risk of leakage as a result from the disinfection procedure of the patient's skin.
A still further drawback related to surgical treatments in general and specifically such surgical treatments using inflatable bags for establishing a limited sterile space is the preparatory work of the surgeon and assistant personal, in particular related to the gloves to be used by the surgeon and the personal. It is known that when putting such surgical gloves on the hands there is a significant risk of contaminating the exterior surface of the glove or damaging the glove due to the difficult handling of the gloves and the thin elastic material the gloves are made from. Further, it is known that taking off such gloves bears the significant risk of contamination to the user of the gloves from infectious substances attached to the exterior surface of the gloves.
In this regard, U.S. Pat. No. 2,741,410 discloses an apparatus for handling contaminated gloves wherein a person may insert his hand with the glove into a box to sealingly engage with the wrist of the person and a vacuum is applied to said box to release the glove from the hand of the person. By this, the taking off of such gloves may be facilitated. However, the apparatus is bulky and requires significant technical means to allow taking off of such gloves. U.S. Pat. No. 4,915,272 discloses a further, more compact apparatus for donning and removing gloves by applying a vacuum to the exterior of the gloves. According to one embodiment, a device having a rigid perforated negative form of a hand with increased dimension is used to insert a hand wearing a surgical glove into said form and to apply a vacuum to take off such a glove. However, whereas this device provides function for taking off the gloves in an efficient procedure, it is rather impossible to use such a device for putting on gloves since a glove cannot be placed inside such a negative form without a hand being inserted into the glove or the form, which is not possible.
A further problem related to sterile limited spaces established on a patient's skin for conducting invasive surgical treatment, is how to provide or exchange surgical instruments and devices inside such limited space for conducting surgical treatments requiring a significant number of such instruments and devices. Generally, any process of introducing such instruments and devices into the limited space inside such an inflatable bag is considered to potentially induce contamination of the sterile atmosphere inside the bag and thus should be avoided. Further, the arrangement of a large number of instruments and devices inside such an inflatable bag is not possible due to the limited space and the range of motion of the surgeon for grasping such instruments.
It is a general object of the invention to provide an option for conducting invasive surgical treatments with less time spent for preparatory work and less risk of infection for the patient. It is a specific object of the invention to provide a device wherein the planning and the logistics of such a surgical treatment can be simplified and is less sensitive to unforeseen events in the course of a surgical treatment.